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Moritz Haigermoser
By Moritz Haigermoser on November 22, 2022

When risks are mentioned, they usually refer to risks related to safety, quality, or data. Rarely, is the reference to risks related to the qualified status of laboratory equipment. However, the results that the particular equipment produces are only trustworthy if the equipment maintains a qualified status. This means that in the absence of proof equipment qualification, your results may be in doubt. Furthermore, your equipment must be qualified for validated processes. If this is not or not anymore the case, the validated process is also at risk. 

Karin Bechberger
By Karin Bechberger
on November 14, 2022

Authors: Karin Bechberger and Julia Ahlhelm

With an increasing amount of data and new technologies, there is a need to differentiate between wasting time and putting effort into non-value-added activities instead of ensuring fitness for the intended use of a computerized system. It is for this reason that the concept of critical thinking was added as an attachment to the 2nd edition of GAMP 5 Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, to enhance risk management in computer system validation.

Tristan Henriques
By Tristan Henriques
on November 03, 2022

Authors: Tristan Henriques & Abel Fernandez Perez

More life science companies than ever are coming to rely upon digital solutions. Today’s digitalization advancements are helping companies optimize and centralize their production activities, driving improvements in process quality and product safety. While the value of digital transformation is clear, implementing it while staying compliant with GxP standards is challenging. That’s because an investment and GAMP 5 category 1 software tools and IT infrastructure requires some level of reliance upon outside vendors that aren’t GxP-regulated. 

Thomas Cullum
By Thomas Cullum
on October 25, 2022

Authors: Thomas Cullum & Julia Ahlhelm

Artificial intelligence (AI) and machine learning (ML) algorithms have been significant drivers of innovation in recent years, allowing for new applications for data analytics and automation. In many industries, AI and ML have already delivered evidence of their importance in improving and optimizing processes. For this reason, their implementation in the pharmaceutical industry is essential. 

Roberto Orlandini
By Roberto Orlandini
on October 24, 2022

A number of industries are exploring the possible advantages of incorporating blockchain as a highly secure form of transmitting data. However, until recently, there has been little guidance on how the pharma industry might adopt blockchain technology without fear of putting patient safety, product quality, and data integrity at risk.